Kanec USA Inc., is recalling all lots of its Nite Rider Maximum Sexual Enhancer For Men and STUD Capsule for Men.
The products were found adulterated with Sildenafil, a Food and Drug Administration- (FDA) approved drug used in the treatment of Erectile Dysfunction (ED), making the products unapproved new drugs.
Possible dangers
Use of herbal supplement capsule products could pose a threat to consumers because the drug may interact with nitrates found in some prescription drugs (such as Nitroglycerin) and may lower blood pressure to dangerous levels.
Consumers with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates. ED is a common problem in men with these conditions and many seek these types of products to enhance sexual performance.
Nite Rider Maximum Sexual Enhancer For Men and STUD Capsules for Men are currently being distributed to wholesalers in Florida. The products are sold in a blister pack of one capsule per unit of use, 24 packets in a display box. Consumers who have either of these products in their possession should stop use immediately.
Consumer action
In the event of any adverse side effects due to the use of this product, consumers are urged to contact a physician immediately. Any adverse events that may be related to the use of this product should be reported to the FDA’s Medwatch program either online, by regular mail, using postage-paid, pre-addressed Form FDA 3500 available here and sending it to the address on the pre-addressed form or by fax at 1-800-FDA-0178.
The company is advising consumers to discard any unused Nite Rider Maximum Sexual Enhancer For Men and STUD Capsule For Men products or return them to the retail location from which it was purchased.
Consumers wishing to return unused capsules directly to the company may send it to Kanec USA, Inc. 5061 South State Road 7, Ste 602, Davie Fla. 33314.
Kanec says it conducts stringent quality testing of its raw materials and finished products, but notes that previous testing protocols did not include a test for the presence of Sildenafil or its analogues.
The company says this deficiency is being rectified, that it regrets any inconvenience to consumers and that it is working closely with the FDA in the recall process.
